A traditional Chinese medicine composition, external preparation and cosmetic product with soothing and repairing effects

Abstract

The application relates to a traditional Chinese medicine composition with soothing and repairing effects, an external preparation and a cosmetic, wherein the traditional Chinese medicine composition is composed of Radix Ampelopsis, Herba Moslae, Radix Angelicae Pubescentis and Uncaria gambier, the Radix Ampelopsis comprises Radix Ampelopsis material and / or Radix Ampelopsis extract, the Herba Moslae comprises Herba Moslae material and / or Herba Moslae extract, the Radix Angelicae Pubescentis comprises Radix Angelicae Pubescentis material and / or Radix Angelicae Pubescentis extract, and the Uncaria gambier comprises Uncaria gambier material and / or Uncaria gambier extract. The traditional Chinese medicine composition is reasonably and scientifically matched by components, combines the prescription idea of a monarch, ministers and assistants in traditional Chinese medicine, realizes synergistic effects of the prescription, and has excellent anti-inflammatory, anti-allergic and antioxidant effect activities, is mild and non-irritating, can comprehensively soothe and repair the skin, and effectively solves the skin health problems of sensitive skin people.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of traditional Chinese medicine compositions, and in particular to a traditional Chinese medicine composition with soothing and repairing effects, an external preparation, and a cosmetic. BACKGROUND

[0002] With the gradual improvement of living standards and the increase of life pressure, the sensitive skin population gradually increases, which is manifested as skin redness, itching, acne skin, etc., and causes certain influence on physical and mental health. At present, some soothing and repairing external products can quickly treat or repair the skin, but they are easy to damage the skin barrier, and thus the symptoms are easy to repeat or deepen. Related skin care products with repairing effects also contain chemical ingredients such as preservatives, which can irritate the skin. Therefore, more and more consumers begin to pay attention to the source of product ingredients. Compared with chemical synthetic ingredients, Chinese herbal medicine ingredients have the characteristics of naturalness and safety, which meet the current pursuit of green environmental protection and are deeply loved by consumers. However, the molecular structure of the active ingredients of Chinese herbal medicine is complex, the transdermal absorption rate is low, it is difficult to effectively penetrate into the deep layer of the skin to play a role, the utilization rate of active ingredients is low, and the soothing and repairing effects of Chinese herbal medicine ingredients are difficult to guarantee. In addition, the stability of products containing Chinese medicine ingredients is poor, and they are easy to be affected by the environment and appear precipitation and other phenomena, which affect the efficacy of the products. Therefore, it is still very important to develop a Chinese herbal medicine ingredient product with high activity and high stability to solve the skin health problems of the sensitive skin population. SUMMARY

[0003] Therefore, it is necessary to provide a traditional Chinese medicine composition with soothing and repairing effects, high stability, and safety and no irritation, to solve the skin health problems of the sensitive skin population.

[0004] In a first aspect, the present application provides a traditional Chinese medicine composition with soothing and repairing effects, the composition of the traditional Chinese medicine composition comprising Radix Ampelopsis, Herba Moslae, Radix Angelicae Pubescentis and Uncaria gambier, the Radix Ampelopsis comprising Radix Ampelopsis medicinals and / or Radix Ampelopsis extract, the Herba Moslae comprising Herba Moslae medicinals and / or Herba Moslae extract, the Radix Angelicae Pubescentis comprising Radix Angelicae Pubescentis medicinals and / or Radix Angelicae Pubescentis extract, and the Uncaria gambier comprising Uncaria gambier medicinals and / or Uncaria gambier extract.

[0005] In some embodiments, the mass content of total polyphenols in the Radix Ampelopsis is ≥8%; and / or, the mass content of total flavonoids in the Herba Moslae is ≥5%; and / or, the mass content of coumarin ingredients in the Radix Angelicae Pubescentis is ≥3%; and / or, the mass content of catechin ingredients in the Uncaria gambier is ≥15%.

[0006] In some embodiments, the traditional Chinese medicine composition further satisfies at least one of the following characteristics (1)-(6):

[0007] (1) The composition of the traditional Chinese medicine composition comprises 10-20 parts of white peony root, 8-20 parts of shixiangru, 1-10 parts of fangchi danggui and 1-10 parts of catechu gou teng;

[0008] (2) The composition of the traditional Chinese medicine composition also includes a solvent;

[0009] (3) The extract of *Bletilla striata* was prepared by extracting the medicinal material with an extraction solvent;

[0010] (4) The extract of Angelica sinensis was prepared by extracting Angelica sinensis with a solvent;

[0011] (5) The extract of Elsholtzia ciliata was prepared by supercritical extraction of Elsholtzia ciliata.

[0012] (6) The extract of catechuic uncaria was prepared by supercritical extraction of the catechuic uncaria medicinal material.

[0013] In some embodiments, the traditional Chinese medicine composition having soothing and restorative effects further satisfies at least one of the following (1) to (10):

[0014] (1) The solvent includes one or more of polyols and water;

[0015] (2) The ratio of the total mass of the above-mentioned white peony root, the above-mentioned elm bark, the above-mentioned angelica root, and the above-mentioned catechu uncaria to the mass of the solvent is (0.5-1.5):(50-70);

[0016] (3) The extraction solvent includes one or more of water and organic solvents;

[0017] (4) The mass ratio of the white peony root and the red angelica root to the extraction solvent is 1:(10-20).

[0018] (5) The pressure for supercritical extraction is 20MPa-40MPa;

[0019] (6) The temperature for supercritical extraction is 40℃-50℃;

[0020] (7) The separation pressure of supercritical extraction is 5MPa-10MPa;

[0021] (8) The separation temperature of supercritical extraction is 30℃-70℃;

[0022] (9) The solvent for supercritical extraction is one or more of water and organic solvents;

[0023] (10) Supercritical extraction includes supercritical CO2 extraction.

[0024] Secondly, this application provides a method for preparing the traditional Chinese medicine composition with soothing and restorative effects described in the first aspect, comprising the following steps:

[0025] A traditional Chinese medicine composition with soothing and restorative effects was prepared by mixing Ampelopsis japonica, Elsholtzia ciliata, Angelica sinensis, and Uncaria rhynchophylla.

[0026] In some embodiments, microfluidic treatment is employed during the mixing process, wherein the microfluidic treatment operates at a temperature of 0°C to 70°C and a pressure of 1000psi to 30000psi; and / or, a solvent is added during the mixing process.

[0027] Thirdly, this application provides a topical preparation comprising the traditional Chinese medicine composition with soothing and repairing effects provided in the first aspect or the traditional Chinese medicine composition with soothing and repairing effects prepared by the preparation method provided in the second aspect, and excipients.

[0028] In some embodiments, the amount of the traditional Chinese medicine composition with soothing and repairing effects added to the topical preparation is 0.5%-10% by mass; and / or, the excipients include one or more of fillers, diluents, lubricants, wetting agents and binders; and / or, the dosage form of the topical preparation includes powders, ointments, pills, tinctures, tablets, liquids, aerosols or poultices.

[0029] Fourthly, this application provides a cosmetic product, the ingredients of which include the traditional Chinese medicine composition with soothing and repairing effects provided in the first aspect or the traditional Chinese medicine composition with soothing and repairing effects prepared by the preparation method provided in the second aspect, as well as additives.

[0030] In some embodiments, the cosmetic product also satisfies at least one of the features shown in (1) to (4) below:

[0031] (1) The amount of the traditional Chinese medicine composition added to the cosmetic is 0.5%-10% by mass;

[0032] (2) The additives include one or more of the following: humectants, surfactants, antioxidants, and stabilizers;

[0033] (3) The cosmetics are available in the form of cream, liquid, lotion or foam;

[0034] (4) The cosmetics include serums, creams, masks or cleansers.

[0035] Compared with traditional technologies, the beneficial effects of this application include:

[0036] This application provides a traditional Chinese medicine composition with soothing and repairing effects. By rationally and scientifically combining *Bai Lian*, *Shi Xiang Ru*, *Chong Chi Mao Dang Gui*, and *Euonymus alatus*, and adjuvanting *Gou Teng*, and adjuvanting according to the principles of traditional Chinese medicine ("principal, assistant, adjuvant, and guide"), the composition achieves synergistic effects. The soothing and repairing traditional Chinese medicine composition provided by this application exhibits excellent anti-inflammatory, anti-allergic, and antioxidant activities, is gentle and non-irritating, and can comprehensively soothe and repair the skin. Simultaneously, the soothing and repairing traditional Chinese medicine composition provided by this application has excellent permeability and stability, which can further enhance the synergistic effect between components and improve the storage performance of the traditional Chinese medicine composition. Detailed Implementation

[0037] To facilitate understanding of this application, a more complete description of the application will be provided below with reference to relevant embodiments. Preferred embodiments of the application are shown in the embodiments. However, the application can be implemented in many different forms and is not limited to the embodiments described herein. Rather, these embodiments are provided to provide a thorough and complete understanding of the disclosure of this application.

[0038] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this application belongs. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the application.

[0039] As used herein, "optional," "optional," and "optional" refer to either "with" or "without" parallel options. If multiple "optional" entries appear in a technical solution, each "optional" entry is independent unless otherwise specified and there are no contradictions or mutual constraints. The term "and / or" as used herein includes any and all combinations of one or more related listed items. Unless otherwise specified, "multiple," "multiple," etc., as used herein refer to a quantity greater than 2 or equal to 2; for example, "one or more" indicates one, two, or more than two. In open-ended technical features or solutions described herein using words such as "containing," "including," and "comprising," unless otherwise specified, additional members beyond the listed members are not excluded. This can be considered as providing both a closed-ended feature or solution consisting of the listed members and an open-ended feature or solution that includes additional members beyond the listed members.

[0040] In this application, in "the first aspect", "the second aspect", "the third aspect", "the fourth aspect", etc., the terms "first", "second", "third", "fourth", etc. are only for descriptive purposes and cannot be construed as indicating or implying relative importance or quantity, nor can they be construed as implicitly indicating the importance or quantity of the indicated technical features. Moreover, "first", "second", "third", "fourth", etc. only serve the purpose of non-exhaustive enumerative description and should be understood not to constitute a closed limitation on quantity.

[0041] If there is no special indication, all implementation manners and optional implementation manners of this application can be combined with each other to form a new technical solution.

[0042] Traditional drugs or skin care products for skin treatment or repair contain some chemically synthesized components, which have certain irritations. While treating and repairing, they are also likely to damage the skin barrier and prone to recurrence and deepening of inflammation. Therefore, more and more consumers pay more attention to products with natural active ingredients. However, the active ingredient structures of natural active ingredients are complex, the transdermal absorption rate is low, it is difficult to effectively penetrate into the deep layer of the skin to play a role. During the treatment and repair process, the time is long, the curative effect is limited, and at the same time, the synergistic efficacy activity is weak, resulting in a single efficacy activity and being difficult to meet the needs of daily life. This application aims to provide a highly active traditional Chinese medicine composition for repairing the skin barrier, and at the same time, it also has diversified efficacy activities, such as antioxidant, anti-allergy and other efficacy traditional Chinese medicine compositions.

[0043] In a first aspect, this application provides a traditional Chinese medicine composition with a soothing and repairing efficacy. The composition of the traditional Chinese medicine composition includes Ampelopsis japonica, Mosla chinensis Maxim., Angelica pubescens Maxim. f. biserrata Shan et Yuan, and Uncaria gambir. The Ampelopsis japonica includes Ampelopsis japonica medicinal materials and / or Ampelopsis japonica extracts. The Mosla chinensis Maxim. includes Mosla chinensis Maxim. medicinal materials and / or Mosla chinensis Maxim. extracts. The Angelica pubescens Maxim. f. biserrata Shan et Yuan includes Angelica pubescens Maxim. f. biserrata Shan et Yuan medicinal materials and / or Angelica pubescens Maxim. f. biserrata Shan et Yuan extracts. The Uncaria gambir includes Uncaria gambir medicinal materials and / or Uncaria gambir extracts.

[0044] In the traditional Chinese medicine composition of this application, Ampelopsis japonica is added as the monarch drug, mainly playing a leading role in antioxidant. Its rich polyphenol components can effectively scavenge free radicals, delay skin aging, and provide basic support for the core efficacy. Mosla chinensis Maxim. is added as the minister drug in the traditional Chinese medicine composition of this application, which acts synergistically with the monarch drug Ampelopsis japonica to play the function of anti-pathogenic microorganisms. Its antibacterial components can effectively inhibit harmful bacteria on the skin surface and prevent skin infections. Through reasonable proportioning, the synergistic effect of Mosla chinensis Maxim. and Ampelopsis japonica can significantly enhance the overall efficacy of the cosmetic raw materials, strengthen the antibacterial and antioxidant capabilities of the product, and provide more comprehensive protection for skin health. Angelica pubescens Maxim. f. biserrata Shan et Yuan is added as the assistant drug in the traditional Chinese medicine composition of this application, which plays a role in enhancing efficacy and harmonizing in the traditional Chinese medicine composition. Its characteristic of promoting microcirculation can enhance the skin's nutrient supply and metabolic capacity, and further improve the antioxidant and anti-aging effects. At the same time, Angelica pubescens Maxim. f. biserrata Shan et Yuan can also reduce the irritation of other components, make the whole traditional Chinese medicine composition milder, reduce adverse reactions to the skin, and improve the safety of the product. Acacia catechu is added as the courier drug in the traditional Chinese medicine composition of this application, mainly responsible for regulating the pH value and dosage form stability of the prescription. Its components can keep the pH value of the cosmetic raw materials within an appropriate range, ensuring the stability and safety of the product. Acacia catechu also has a certain astringent effect, which can shrink skin pores, make the skin more delicate and smooth, and further improve the use effect and sensory experience of the product.

[0045] The traditional Chinese medicine composition provided by this application realizes the synergistic effect of the prescription through reasonable scientific proportioning of the traditional Chinese medicine prescription and combining the prescription idea of "monarch, minister, assistant, and courier" in traditional Chinese medicine. Through the synergistic effect of Ampelopsis japonica, Mosla chinensis Maxim., Angelica pubescens Maxim. f. biserrata Shan et Yuan, and Uncaria rhynchophylla, the skin barrier repair function activity of the traditional Chinese medicine composition is significantly improved, the penetration performance of the composition components is enhanced, and a synergistic multi-effect activity is generated to meet people's daily skin care needs.

[0046] Controlling the content of each component in the prescription of the traditional Chinese medicine composition within a certain range is the core element to ensure its safety, effectiveness, and quality stability. This process involves multidisciplinary theories such as traditional Chinese medicine pharmacology, pharmaceutics, and quality control. By controlling the component content of Ampelopsis japonica, Mosla chinensis Maxim., Angelica pubescens Maxim. f. biserrata Shan et Yuan, and Uncaria rhynchophylla within a certain range, this application can better achieve the synergistic effect of each prescription, thereby further obtaining a higher skin barrier repair efficacy activity.

[0047] In some embodiments, the total polyphenol content of *Ampelopsis japonica* in the traditional Chinese medicine composition is ≥8% by mass. When the total polyphenol content of *Ampelopsis japonica* is ≥8% by mass, the traditional Chinese medicine composition of this application has a higher skin barrier repair effect, can better scavenge free radicals, delay skin aging, and fully exert its principal drug role in the formulation of the traditional Chinese medicine composition. As a non-limiting example, the total polyphenol content of *Ampelopsis japonica* in the traditional Chinese medicine composition being ≥8% by mass includes the total polyphenol content of *Ampelopsis japonica* medicinal material being ≥8% by mass, or the total polyphenol content of *Ampelopsis japonica* extract being ≥8% by mass, or the total polyphenol content of a mixture of *Ampelopsis japonica* medicinal material and *Ampelopsis japonica* extract being ≥8% by mass. Further, the total polyphenol content of *Ampelopsis japonica* in the traditional Chinese medicine composition of this application is 8%-24% by mass, within which the technical effects of this application can be better achieved. As a non-limiting example, the total polyphenol content of *Ampelopsis japonica* medicinal material and / or *Ampelopsis japonica* extract in the traditional Chinese medicine composition of this application is 8%-24% by mass. Including but not limited to 8%, 12%, 16%, 20%, 24% or any two of the foregoing, and the values ​​within that range.

[0048] In some embodiments, the total flavonoid content of *Elsholtzia ciliata* in the traditional Chinese medicine composition is ≥5% by mass. When the total flavonoid content of *Elsholtzia ciliata* is ≥5% by mass, it can better synergistically enhance the skin barrier repair effect with *Ampelopsis japonica*, thereby improving activity. Simultaneously, when the total flavonoid content of *Elsholtzia ciliata* is ≥5% by mass, it can produce better antibacterial and antioxidant activity, inhibit harmful bacteria on the skin surface, prevent skin infections, promote skin repair, and fully exert its assistant drug role in the traditional Chinese medicine composition. As a non-limiting example, the total flavonoid content of *Elsholtzia ciliata* in the traditional Chinese medicine composition being ≥5% by mass includes the total flavonoid content of the *Elsholtzia ciliata* herb being ≥5% by mass, or the total flavonoid content of the *Elsholtzia ciliata* extract being ≥5% by mass, or the total flavonoid content of the mixture of the *Elsholtzia ciliata* herb and the *Elsholtzia ciliata* extract being ≥5% by mass. Further, the total flavonoid content of *Elsholtzia ciliata* in the traditional Chinese medicine composition of this application is 5%-15% by mass, within which the technical effects of this application can be better achieved. As a non-limiting example, the total flavonoid content of the *Elsholtzia ciliata* herb and / or the *Elsholtzia ciliata* extract in the traditional Chinese medicine composition of this application is 5%-15% by mass. This includes, but is not limited to, 5%, 7%, 9%, 11%, 13%, 15%, or any combination thereof and values ​​within that range.

[0049] In some embodiments, the coumarin content of *Angelica sinensis* in the traditional Chinese medicine composition is ≥3% by mass. When the coumarin content of *Angelica sinensis* is ≥3% by mass, it can better synergistically enhance the skin barrier repair effect with *Ampelopsis japonica* and *Elsholtzia ciliata*, while also reducing the irritation of the traditional Chinese medicine composition, making it milder. When the coumarin content of *Angelica sinensis* is ≥3% by mass, it can promote microcirculation, thereby enhancing the skin's nutrient supply and metabolic capacity, further improving antioxidant and anti-aging effects, promoting skin repair, and fully exerting its adjuvant role in the traditional Chinese medicine composition. As a non-limiting example, the coumarin content of *Angelica sinensis* in the traditional Chinese medicine composition being ≥3% by mass includes the coumarin content of *Angelica sinensis* herbal material being ≥3% by mass, or the coumarin content of *Angelica sinensis* extract being ≥3% by mass, or the coumarin content of a mixture of *Angelica sinensis* herbal material and *Angelica sinensis* extract being ≥3% by mass. Furthermore, the coumarin content of *Angelica sinensis* in the traditional Chinese medicine composition of this application is 3%-10% by mass, which better achieves the technical effects of this application within this range. As a non-limiting example, the coumarin content of *Angelica sinensis* medicinal material and / or *Angelica sinensis* extract in the traditional Chinese medicine composition of this application is 3%-10% by mass. This includes, but is not limited to, 3%, 5%, 7%, 9%, 10%, or any of the foregoing ranges and values ​​within those ranges.

[0050] In some embodiments, the catechin content of Uncaria rhynchophylla in the traditional Chinese medicine composition is ≥15% by mass. When the catechin content of Uncaria rhynchophylla is ≥15% by mass, it can better synergistically enhance the skin barrier repair effect with Ampelopsis japonica and Elsholtzia ciliata, while also reducing the irritation of the traditional Chinese medicine composition, making the composition milder. When the catechin content of Uncaria rhynchophylla is ≥3% by mass, it can promote microcirculation, thereby enhancing the skin's nutrient supply and metabolic capacity, further improving the antioxidant and anti-aging effects, promoting skin repair, and fully exerting its adjuvant role in the traditional Chinese medicine composition. As a non-limiting example, the catechin content of Uncaria rhynchophylla in the traditional Chinese medicine composition being ≥15% by mass includes the catechin content of Uncaria rhynchophylla herbal material being ≥15% by mass, or the catechin content of Uncaria rhynchophylla extract being ≥15% by mass, or the catechin content of a mixture of Uncaria rhynchophylla herbal material and Uncaria rhynchophylla extract being ≥15% by mass. Furthermore, the catechin content of Uncaria rhynchophylla in the traditional Chinese medicine composition of this application is 15%-25% by mass, which better achieves the technical effects of this application within this range. As a non-limiting example, the catechin content of Uncaria rhynchophylla and / or Uncaria rhynchophylla extract in the traditional Chinese medicine composition of this application is 15%-25% by mass. This includes, but is not limited to, 15%, 17%, 19%, 21%, 25%, or any combination thereof and values ​​within that range.

[0051] In some embodiments, the traditional Chinese medicine composition comprises, by weight, 10-20 parts of *Ampelopsis japonica*, 8-20 parts of *Elsholtzia ciliata*, 1-10 parts of *Angelica sinensis*, and 1-10 parts of *Uncaria rhynchophylla*.

[0052] In some embodiments, the traditional Chinese medicine composition comprises, by weight, 10-15 parts of *Bai Lian*, 8-15 parts of *Shi Xiang Ru*, 3-8 parts of *Chong Chi Mao Dang Gui*, and 1-5 parts of *Catechu Gou Teng*.

[0053] In some embodiments, the traditional Chinese medicine composition comprises, by weight, 10-15 parts of *Bai Lian*, 8-12 parts of *Shi Xiang Ru*, 4-6 parts of *Chong Chi Mao Dang Gui*, and 2-4 parts of *Catechu Gou Teng*.

[0054] In some embodiments, the composition of the traditional Chinese medicine composition further includes a solvent.

[0055] In some embodiments, the solvent comprises one or more of a polyol and water. As a non-limiting example, the polyol comprises one or more of butanediol, 1,2-propanediol, glycerol, and 1,3-propanediol.

[0056] In some embodiments, the total mass fraction of the ingredients of *Bai Lian*, *Shi Xiang Ru*, *Chong Chi Mao Dang Gui*, and *Catechu Gou Teng*, and the mass fraction of the solvent, is (0.5-1.5):(50-70). This includes, but is not limited to, 0.5:50, 0.5:60, 0.5:70, 1:50, 1:60, 1:70, 1.5:50, 1.5:60, 1.5:70, or any range formed by both of the foregoing and values ​​within that range.

[0057] In the traditional Chinese medicine composition of this application, the types and contents of active ingredients contained in each component play an important role in the skin barrier repair effect of the traditional Chinese medicine composition of this application.

[0058] The extraction method of Chinese medicinal herbs has a significant impact on the composition and efficacy of the extracts. The extraction methods of the extracts of each Chinese medicinal herb in the Chinese medicine composition described in this application are as follows:

[0059] In some embodiments, the *Bletilla striata* extract is prepared by extracting the *Bletilla striata* medicinal material using an extraction solvent.

[0060] In some embodiments, the extraction solvent includes one or more of water and organic solvents, wherein the organic solvent includes alcohol solvents. The *Ampelopsis japonica* extract includes an aqueous extract or an alcoholic extract of *Ampelopsis japonica*.

[0061] As a non-limiting example, alcohol solvents include ethanol. In some embodiments, the ethanol comprises 70%-80% by mass. As a non-limiting example, this includes, but is not limited to, 70%, 72%, 75%, 78%, 80%, or any combination thereof and values ​​within that range.

[0062] In some embodiments, the mass ratio of material to liquid during the extraction process (the mass ratio of the white peony root to the extraction solvent) is 1:(10-20). As a non-limiting example, it includes, but is not limited to, 1:10, 1:12, 1:15, 1:18, 1:20 or any of the foregoing ranges and values ​​within those ranges.

[0063] In some embodiments, the extraction time is 1h-3h. As a non-limiting example, it includes, but is not limited to, 1h, 1.5h, 2h, 2.5h, 3h, or any range formed by both of the foregoing and values ​​within that range.

[0064] In some embodiments, the number of extractions is 1 to 3. As a non-limiting example, this includes, but is not limited to, 1, 2, 3 extractions or any combination thereof, and values ​​within that range.

[0065] In some embodiments, the extraction process further includes purification, specifically column chromatography of the extract. As a non-limiting example, the column chromatography comprises macroporous resins, including D101 and / or AB-8 macroporous resins.

[0066] In some embodiments, the elution solvent for column chromatography includes one or more of methanol, ethanol, ethyl acetate, isopropanol, and acetone.

[0067] In some embodiments, freeze-drying the extract at low temperatures can better preserve the activity of the active ingredients in the extract.

[0068] In some embodiments, the *Angelica sinensis* extract is prepared by extracting the *Angelica sinensis* herb with an extraction solvent.

[0069] In some embodiments, the extraction solvent includes one or more of water and organic solvents, wherein the organic solvent includes alcohol solvents. The *Angelica sinensis* extract comprises an aqueous extract or an alcoholic extract of *Angelica sinensis*.

[0070] As a non-limiting example, alcohol solvents include ethanol. In some embodiments, the ethanol comprises 70%-80% by mass. As a non-limiting example, this includes, but is not limited to, 70%, 72%, 75%, 78%, 80%, or any combination thereof and values ​​within that range.

[0071] As a non-limiting example, the alcohol extraction is an ethanol extraction. In some embodiments, the ethanol content is 70%-80% by mass. As a non-limiting example, it includes, but is not limited to, 70%, 72%, 75%, 78%, 80%, or any combination thereof and values ​​within that range.

[0072] In some embodiments, the material-to-liquid mass ratio during the extraction process (the mass ratio of the Angelica sinensis herb to the extraction solvent) is 1:(10-20). As a non-limiting example, it includes, but is not limited to, 1:10, 1:12, 1:15, 1:18, 1:20 or any of the foregoing ranges and values ​​within those ranges.

[0073] In some embodiments, the extraction time is 1h-3h. As a non-limiting example, it includes, but is not limited to, 1h, 1.5h, 2h, 2.5h, 3h, or any range formed by both of the foregoing and values ​​within that range.

[0074] In some embodiments, the number of extractions is 1 to 3. As a non-limiting example, this includes, but is not limited to, 1, 2, 3 extractions or any combination thereof, and values ​​within that range.

[0075] In some embodiments, low-temperature freeze-drying of the extract can better preserve the activity of the active ingredients in the extract.

[0076] In some embodiments, the *Elsholtzia ciliata* extract comprises the *Elsholtzia ciliata* supercritical fluid extract. The *Elsholtzia ciliata* supercritical fluid extract is prepared by supercritical extraction of *Elsholtzia ciliata* medicinal material. As a non-limiting example, the *Elsholtzia ciliata* supercritical fluid extract comprises the *Elsholtzia ciliata* supercritical CO2 extract.

[0077] In some embodiments, the supercritical extraction pressure of Elsholtzia ciliata is 20 MPa-40 MPa. As a non-limiting example, it includes, but is not limited to, 20 MPa, 22 MPa, 25 MPa, 28 MPa, 30 MPa, 35 MPa, 40 MPa, or any of the foregoing ranges and values ​​within those ranges.

[0078] In some embodiments, the supercritical extraction temperature of Elsholtzia ciliata is 40°C-50°C. As a non-limiting example, it includes, but is not limited to, 40°C, 42°C, 45°C, 48°C, 50°C, or any range formed by both of the foregoing and values ​​within that range.

[0079] In some embodiments, the separation temperature of supercritical extraction of Elsholtzia ciliata is 30℃-70℃. As a non-limiting example, it includes, but is not limited to, 30℃, 35℃, 40℃, 45℃, 50℃, 55℃, 60℃, 65℃, 70℃ or any of the foregoing ranges and values ​​within those ranges.

[0080] In some embodiments, the separation pressure of supercritical extraction of Elsholtzia ciliata is 5 MPa-10 MPa. As a non-limiting example, it includes, but is not limited to, 5 MPa, 6 MPa, 7 MPa, 8 MPa, 9 MPa, 10 MPa or any of the foregoing ranges and values ​​within those ranges.

[0081] In some embodiments, the solvent for supercritical extraction of Elsholtzia ciliata is one or more of water and organic solvents. Further, the solvent for supercritical extraction of Elsholtzia ciliata in this application is an organic solvent. As a non-limiting example, the solvent is ethanol. As a non-limiting example, the mass fraction of ethanol is 70%-80%, including but not limited to 70%, 72%, 75%, 78%, 80%, or any range formed by both of the foregoing and values ​​within that range.

[0082] In some embodiments, the extract prepared by supercritical extraction of the herb Elsholtzia ciliata is subjected to low-temperature freeze-drying, which can better preserve the activity of the active ingredients in the extract.

[0083] In some embodiments, the supercritical extract of Uncaria rhynchophylla includes supercritical extract of Uncaria rhynchophylla. The supercritical extract of Uncaria rhynchophylla is prepared by supercritical extraction of Uncaria rhynchophylla. As a non-limiting example, the supercritical extract of Uncaria rhynchophylla includes supercritical CO2 extract of Elsholtzia ciliata.

[0084] In some embodiments, the supercritical extraction pressure of the catechu and Uncaria rhynchophylla herb is 20 MPa-40 MPa. As a non-limiting example, it includes, but is not limited to, 20 MPa, 22 MPa, 25 MPa, 28 MPa, 30 MPa, 35 MPa, 40 MPa, or any of the foregoing ranges and values ​​within those ranges.

[0085] In some embodiments, the supercritical extraction temperature of Uncaria rhynchophylla is 40°C-50°C. As a non-limiting example, it includes, but is not limited to, 40°C, 42°C, 45°C, 48°C, 50°C, or any range formed by both of the foregoing and values ​​within that range.

[0086] In some embodiments, the separation temperature of supercritical extraction of catechu and Uncaria rhynchophylla is 30°C-70°C. As a non-limiting example, it includes, but is not limited to, 30°C, 35°C, 40°C, 45°C, 50°C, 55°C, 60°C, 65°C, 70°C or any of the foregoing ranges and values ​​within those ranges.

[0087] In some embodiments, the separation pressure of the supercritical extraction of the catechu and Uncaria rhynchophylla herb is 5 MPa-10 MPa. As a non-limiting example, it includes, but is not limited to, 5 MPa, 6 MPa, 7 MPa, 8 MPa, 9 MPa, 10 MPa or any of the foregoing ranges and values ​​within those ranges.

[0088] In some embodiments, the solvent for supercritical extraction of catechu and Uncaria rhynchophylla is one or more of water and organic solvents. Further, the solvent for supercritical extraction of catechu and Uncaria rhynchophylla in this application is an organic solvent. As a non-limiting example, the solvent is ethanol. As a non-limiting example, the mass fraction of ethanol is 70%-80%, including but not limited to 70%, 72%, 75%, 78%, 80%, or any combination thereof and values ​​within that range.

[0089] In some embodiments, the extract prepared by supercritical extraction of the catechu and Uncaria rhynchophylla herb is subjected to low-temperature freeze-drying, which can better preserve the activity of the active ingredients in the extract.

[0090] Secondly, this application provides a method for preparing the traditional Chinese medicine composition with soothing and restorative effects described in the first aspect, comprising the following steps:

[0091] A traditional Chinese medicine composition with soothing and restorative effects was prepared by mixing Ampelopsis japonica, Elsholtzia ciliata, Angelica sinensis, and Uncaria rhynchophylla.

[0092] In some embodiments, solvents are added during the preparation of the traditional Chinese medicine composition with soothing and restorative effects for mixing.

[0093] In some embodiments, microfluidic treatment is employed during the mixing process. This application uses microfluidic equipment to process the mixture, which can disperse the traditional Chinese medicine composition to the nanoscale, significantly improving the uniformity and stability of the composition, enhancing its permeability during application, and thus better exerting its functional activity.

[0094] In some embodiments, the operating temperature of the microfluidic treatment is 0°C-70°C. As a non-limiting example, this includes, but is not limited to, 0°C, 5°C, 8°C, 10°C, 12°C, 15°C, 20°C, 25°C, 30°C, 40°C, 50°C, 60°C, 70°C, or any range formed by both of the foregoing and values ​​within that range. Furthermore, the use of an operating temperature of 10°C for the microfluidic treatment in this application better achieves the technical effects of this application.

[0095] In some embodiments, the operating pressure of the microjets is between 1000 psi and 30000 psi. As a non-limiting example, this includes, but is not limited to, 1000 psi, 5000 psi, 10000 psi, 15000 psi, 20000 psi, 30000 psi, or any range formed by both of the foregoing and values ​​within that range. Furthermore, the use of a 15000 psi operating pressure in the microjets of this application better achieves the technical effects of this application.

[0096] Thirdly, this application provides a topical preparation comprising the traditional Chinese medicine composition with soothing and repairing effects provided in the first aspect or the traditional Chinese medicine composition with soothing and repairing effects prepared by the preparation method provided in the second aspect, and excipients.

[0097] In some embodiments, the amount of the traditional Chinese medicine composition with soothing and repairing effects added to the topical preparation is 0.5%-10% by mass. As a non-limiting example, it includes, but is not limited to, 0.5%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, or any range formed by both of the foregoing and values ​​within that range.

[0098] In some embodiments, the excipients include one or more of fillers, diluents, lubricants, wetting agents, and binders. As a non-limiting example, the excipients may be pharmaceutically acceptable excipients.

[0099] In some embodiments, the dosage form of the topical preparation includes powder, ointment, pill, tincture, lozenge, liquid, aerosol, or poultice.

[0100] The topical preparation provided in this application can be used for anti-inflammatory, antioxidant, skin barrier repair, or inhibition of Propionibacterium acnes, and has a soothing effect on the skin.

[0101] Fourthly, this application provides a cosmetic product, the ingredients of which include the traditional Chinese medicine composition with soothing and repairing effects provided in the first aspect or the traditional Chinese medicine composition with soothing and repairing effects prepared by the preparation method provided in the second aspect, as well as additives.

[0102] In some embodiments, the amount of the traditional Chinese medicine composition with soothing and repairing effects added to the cosmetic is 0.5%-10% by mass. As a non-limiting example, it includes, but is not limited to, 0.5%, 1%, 2%, 3%, 4%, 5%, 6%, 7%, 8%, 9%, 10%, or any range formed by both of the foregoing and values ​​within that range.

[0103] In some embodiments, the additive includes one or more of humectants, surfactants, antioxidants, and stabilizers.

[0104] In some embodiments, the cosmetic product may be in the form of a cream, liquid, lotion, or foam.

[0105] In some embodiments, the cosmetic product includes a serum, cream, mask, or cleanser.

[0106] The cosmetics provided in this application can be used for anti-inflammatory, antioxidant, skin barrier repair, or inhibition of Propionibacterium acnes, and have a soothing effect on the skin.

[0107] For experimental parameters not specified in the following specific embodiments, please refer to the guidelines given in this application document first, and also refer to experimental manuals or other experimental methods known in the art, or refer to the experimental conditions recommended by the manufacturer.

[0108] The substrates and reagents used in the following specific embodiments are commercially available or can be prepared by those skilled in the art using known methods.

[0109] Preparation of Gynostemma pentaphyllum extract-1:

[0110] After pulverizing the medicinal material of *Bletilla striata*, it was extracted by reflux with an ethanol-water solution (ethanol content of 70 wt%) at a material-to-liquid ratio (mass ratio) of 1:10, for 2 hours, and twice. The extraction was carried out by filtering with filter cloth and filter membrane (0.45 μm) successively, collecting the filtrate, and then eluting with D101 resin with 50% ethanol as the eluent for 3 BV. The eluent was then subjected to vacuum distillation using a rotary evaporator to remove the ethanol. The solid material was then freeze-dried at low temperature to prepare *Bletilla striata* extract-1, wherein the total polyphenol content of *Bletilla striata* extract-1 is ≥8%.

[0111] Preparation of Gynostemma pentaphyllum extract-2:

[0112] After pulverizing the medicinal material of *Ampelopsis japonica*, it was extracted by reflux with an ethanol-water solution (ethanol content of 75 wt%) at a material-to-liquid ratio (mass ratio) of 1:10, for 1 hour, and for 3 extractions. The material was filtered through a filter cloth and a 0.45 μm filter membrane. The filtrate was collected and then subjected to vacuum distillation using a rotary evaporator to remove the ethanol. The solid material was then freeze-dried at low temperature to prepare *Ampelopsis japonica* extract-2. The total polyphenol content of *Ampelopsis japonica* extract-2 is ≤8%.

[0113] Preparation of Angelica sinensis extract-1:

[0114] After pulverizing the Angelica sinensis 'Hypericum' herb, it was extracted by reflux with an ethanol solution (75wt%) at a material-to-liquid ratio of 1:10, for 1 hour, and three times. The extract was filtered through a filter cloth and a 0.45μm filter membrane. The filtrate was collected and then eluted with AB-8 resin with 50% ethanol for 3 BV. The eluent was then subjected to vacuum distillation using a rotary evaporator to remove the ethanol. The solid material was then freeze-dried at low temperature to prepare Angelica sinensis 'Hypericum' extract-1. The coumarin content of Angelica sinensis 'Hypericum' extract-1 is ≥3%.

[0115] Preparation of Angelica sinensis extract-2:

[0116] After pulverizing the Angelica sinensis 'Hypericum' herb, it was extracted by reflux with an ethanol solution (75wt%) at a material-to-liquid ratio (mass ratio) of 1:10, for 1 hour, and three times. The extract was filtered through a filter cloth and a 45μm filter membrane. The filtrate was collected and then subjected to vacuum distillation using a rotary evaporator to remove the ethanol. The solid material was then freeze-dried at low temperature to prepare Angelica sinensis 'Hypericum' extract-2. The coumarin content of Angelica sinensis 'Hypericum' extract-2 is ≤3%.

[0117] Preparation of Elsholtzia ciliata extract-1:

[0118] After pulverizing the medicinal material of Elsholtzia ciliata, it was placed in a supercritical CO2 extraction vessel. The extraction temperature was set at 50℃, the extraction pressure at 35MPa, the separation temperature at 60℃, and the separation pressure at 10MPa. The extraction solvent was an aqueous ethanol solution (ethanol content of 80wt%). After extraction, the filtrate was collected and subjected to vacuum distillation using a rotary evaporator to remove the ethanol. The solid material was then freeze-dried at low temperature to prepare Elsholtzia ciliata extract-1. The total flavonoid content of Elsholtzia ciliata extract-1 was ≥5%.

[0119] Preparation of Elsholtzia ciliata extract-2:

[0120] After pulverizing the medicinal material of Elsholtzia ciliata, it was placed in a supercritical CO2 extraction vessel. The extraction temperature was set at 50℃, the extraction pressure at 15MPa, the separation temperature at 60℃, and the separation pressure at 10MPa. The extraction solvent was an aqueous ethanol solution (ethanol content of 80wt%). After extraction, the filtrate was collected and subjected to vacuum distillation using a rotary evaporator to remove the ethanol. The solid material was then freeze-dried at low temperature to prepare Elsholtzia ciliata extract-2. The total flavonoid content in Elsholtzia ciliata extract-2 was ≤5%.

[0121] Preparation of Uncaria rhynchophylla extract-1:

[0122] After pulverizing the catechu uncaria herb, it was placed in a supercritical CO2 extraction vessel. The extraction temperature was set at 50℃, the extraction pressure at 35MPa, the separation temperature at 60℃, and the separation pressure at 10MPa. The extraction solvent was an aqueous ethanol solution (ethanol content of 80wt%). After extraction, the filtrate was collected and subjected to vacuum distillation using a rotary evaporator to remove the ethanol. The solid material was then freeze-dried at low temperature to prepare catechu uncaria extract-1. The mass content of catechin components in catechu uncaria extract-1 is ≥15%.

[0123] Preparation of Uncaria rhynchophylla extract-2:

[0124] After pulverizing the catechu uncaria herb, it was placed in a supercritical CO2 extraction vessel. The extraction temperature was set at 50℃, the extraction pressure at 15MPa, the separation temperature at 60℃, and the separation pressure at 10MPa. The extraction solvent was an aqueous ethanol solution (ethanol content of 80wt%). After extraction, the filtrate was collected and subjected to vacuum distillation using a rotary evaporator to remove the ethanol. The solid material was then freeze-dried at low temperature to prepare catechu uncaria extract-2. The mass content of catechin components in catechu uncaria extract-2 is ≤15%.

[0125] Example 1

[0126] The traditional Chinese medicine composition with soothing and restorative effects in this embodiment includes: 112g of Ampelopsis japonica extract, 112g of Elsholtzia ciliata extract, 14g of Angelica sinensis extract, and 12g of Uncaria rhynchophylla extract.

[0127] Example 2

[0128] The traditional Chinese medicine composition with soothing and restorative effects in this embodiment includes: 112g of Ampelopsis japonica extract, 110g of Elsholtzia ciliata extract, 15g of Angelica sinensis extract, and 13g of Uncaria rhynchophylla extract.

[0129] Example 3

[0130] The traditional Chinese medicine composition with soothing and restorative effects in this embodiment includes: 113g of Ampelopsis japonica extract, 19g of Elsholtzia ciliata extract, 15g of Angelica sinensis extract, and 13g of Uncaria rhynchophylla extract.

[0131] Example 4

[0132] The traditional Chinese medicine composition with soothing and restorative effects in this embodiment includes: 110g of Ampelopsis japonica extract, 110g of Elsholtzia ciliata extract, 16g of Angelica sinensis extract, and 14g of Uncaria rhynchophylla extract.

[0133] Example 5

[0134] The traditional Chinese medicine composition with soothing and restorative effects in this embodiment includes: 115g of Ampelopsis japonica extract, 18g of Elsholtzia ciliata extract, 14g of Angelica sinensis extract, and 13g of Uncaria rhynchophylla extract.

[0135] Example 6

[0136] The traditional Chinese medicine composition with soothing and repairing effects in this embodiment includes: 114g of Ampelopsis japonica extract, 110g of Elsholtzia ciliata extract, 14g of Angelica sinensis extract, and 12g of Uncaria rhynchophylla extract.

[0137] Example 7

[0138] The traditional Chinese medicine composition with soothing and restorative effects in this embodiment includes: 1.5g of Ampelopsis japonica extract, 1.6g of Elsholtzia ciliata extract, 1.4g of Angelica sinensis extract, and 1.2g of Uncaria rhynchophylla extract.

[0139] Example 8

[0140] The traditional Chinese medicine composition with soothing and repairing effects in this embodiment includes: 121g of Ampelopsis japonica extract, 111g of Elsholtzia ciliata extract, 114g of Angelica sinensis extract, and 0.2g of Uncaria rhynchophylla extract.

[0141] Example 9

[0142] The traditional Chinese medicine composition with soothing and repairing effects in this embodiment includes: 12g of Ampelopsis japonica extract, 12g of Elsholtzia ciliata extract, 4g of Angelica sinensis extract, and 2g of Uncaria rhynchophylla extract.

[0143] Example 10

[0144] The traditional Chinese medicine composition with soothing and repairing effects in this embodiment includes: 2 12g of Ampelopsis japonica extract, 1 12g of Elsholtzia ciliata extract, 2 4g of Angelica sinensis extract, and 1 2g of Uncaria rhynchophylla extract.

[0145] The preparation methods of the traditional Chinese medicine compositions with soothing and repairing effects in Examples 1-10 are as follows:

[0146] According to the formula, extracts of *Ampelopsis japonica*, *Elsholtzia ciliata*, *Angelica sinensis*, and *Uncaria rhynchophylla* were mixed, and then 1100g of water and 700g of 1,3-propanediol were added and mixed. The mixture was then processed using a low-temperature microfluidic device at a working temperature of 10℃ and a working pressure of 15000psi, and the process was repeated three times to prepare a traditional Chinese medicine composition with soothing and repairing effects. The particle size of the traditional Chinese medicine composition was 56nm.

[0147] Example 11

[0148] The traditional Chinese medicine composition with soothing and restorative effects in this embodiment includes: 112g of Ampelopsis japonica extract, 112g of Elsholtzia ciliata extract, 14g of Angelica sinensis extract, and 12g of Uncaria rhynchophylla extract.

[0149] The preparation method is as follows: according to the formula, the extracts of Ampelopsis japonica, Elsholtzia ciliata, Angelica sinensis, and Uncaria rhynchophylla are mixed, and then 1100g of water and 700g of 1,3-propanediol are added and mixed. The mixture is stirred for 1 hour at a stirring speed of 500 rpm to prepare a traditional Chinese medicine composition with soothing and repairing effects. The particle size of the traditional Chinese medicine composition is 1225nm.

[0150] Comparative Example 1

[0151] The composition of the traditional Chinese medicine in this comparative example includes: 112g of Ampelopsis japonica extract and 112g of Elsholtzia ciliata extract.

[0152] Comparative Example 2

[0153] The composition of the traditional Chinese medicine in this comparative example includes: 112g of Ampelopsis japonica extract and 112g of Uncaria rhynchophylla extract.

[0154] Comparative Example 3

[0155] The composition of the traditional Chinese medicine in this comparative example includes: 112g of Elsholtzia splendens extract and 112g of Angelica sinensis extract.

[0156] Comparative Example 4

[0157] The composition of the traditional Chinese medicine in this comparative example includes: 112g of Ampelopsis japonica extract, 112g of Angelica sinensis extract, and 112g of Uncaria rhynchophylla extract.

[0158] Comparative Example 5

[0159] The traditional Chinese medicine composition of this comparative example includes: 112g of Ampelopsis japonica extract, 112g of Angelica sinensis extract, 112g of Uncaria rhynchophylla extract, and 12g of Scutellaria baicalensis extract.

[0160] The preparation method of Scutellaria baicalensis extract is as follows: Scutellaria baicalensis is pulverized and extracted three times with eight times the amount of 70wt% ethanol, each time for 2 hours. The filtrates are combined and concentrated into powder under reduced pressure to obtain Scutellaria baicalensis extract.

[0161] The preparation methods of the traditional Chinese medicine compositions in Comparative Examples 1-5 are the same as those in Examples 1-10.

[0162] To verify the efficacy and activity of the traditional Chinese medicine composition of this application, the antioxidant properties, anti-inflammatory activity, and stability of the traditional Chinese medicine compositions prepared in the above examples and comparative examples were verified. The efficacy, activity, and stability described in the traditional Chinese medicine composition were verified by tests such as DPPH free radical scavenging test, inhibition of inflammatory factor IL-6, and inhibition of inflammatory factor NO.

[0163] Experimental Example 1: Stability Test of Traditional Chinese Medicine Composition

[0164] The stability of the traditional Chinese medicine composition samples prepared in Examples 1-11 and Comparative Examples 1-5 was tested, and the physical state, color and odor of the samples were analyzed, tested and recorded. The samples were stored in sealed clean packaging materials and preserved for 90 days under the following four conditions: high temperature (50℃), low temperature (-15℃), natural light (room temperature), and room temperature in the dark for 3 months. The storage environment temperature was 25℃±5℃, and the storage environment humidity was 50%RH±20%. Changes in the morphology (color, odor, state) of the samples were observed at 0, 30, 60, and 90 days. The data of 30, 60, and 90 days were compared with those of 0 days to determine the stability of the traditional Chinese medicine formulation. The results showed that the traditional Chinese medicine composition samples of Examples 1-11 were brown transparent liquids with a special odor. On day 0, all samples met the standard (no precipitation, no color change). On day 30, sample 11 showed precipitation, while the other samples did not show significant changes and met the standard (no precipitation, no color change). On days 60 and 90, sample 11 showed severe precipitation, while the other samples did not show significant changes and met the standard (no precipitation, no color change). It is evident that the stability of the sample from Example 11, which was not treated with low-temperature microfluidic jet, differed significantly from that of the samples from Examples 1-10, which were treated with low-temperature microfluidic jet. The traditional Chinese medicine composition sample treated with low-temperature microfluidic jet showed good stability within 3 months, and no abnormalities were observed.

[0165] Experimental Example 2: Antioxidant Activity Test of Traditional Chinese Medicine Composition

[0166] The antioxidant activity of the traditional Chinese medicine compositions prepared in Examples 1-11 and Comparative Examples 1-5 was tested using the following methods:

[0167] Accurately weigh 41.67 mg of DPPH reagent and dilute to 100 mL in a brown volumetric flask. Take 5 mL of the solution and dilute to 50 mL in a brown volumetric flask with anhydrous ethanol to obtain the DPPH test solution (0.1 mmol / L). Transfer 1 mL of the DPPH test solution to each sample and add 0.5 mL of any of the 2 wt% concentrations of Examples 1-11 and Comparative Examples 1-5. Mix thoroughly and let stand in the dark for 30 min. Use anhydrous ethanol as a blank control and measure the absorbance at 517 nm. Use vitamin C as a control. Calculate the DPPH scavenging rate of each sample at the 2 wt% concentration according to the following formula (1).

[0168] (1)

[0169] In the formula: A s —Absorbance of the sample solution in the DPPH reaction system; A r —Absorbance of sample solution-anhydrous ethanol; A0 —Absorbance of blank control-anhydrous ethanol.

[0170] The results obtained by the above testing method are shown in Table 1.

[0171] Table 1: Results of Antioxidant Activity Tests of Traditional Chinese Medicine Compositions

[0172]

[0173] As shown in Table 1, compared with Comparative Examples 1-5, the traditional Chinese medicine composition samples prepared in Examples 1-11 have a higher DPPH free radical scavenging rate, with Examples 1-6 showing the best scavenging rate. This indicates that the scientifically formulated traditional Chinese medicine composition has better antioxidant effects, can effectively alleviate the degradation of cell structure and function under the action of excessive free radicals generated after external stimulation, and has a good effect on promoting skin barrier repair.

[0174] Experimental Example 3: Hyaluronidase Activity Inhibition Test of Traditional Chinese Medicine Composition

[0175] Hyaluronidase activity inhibition tests were performed on the traditional Chinese medicine composition samples prepared in Examples 1-11 and Comparative Examples 1-5. The test methods are as follows:

[0176] The in vitro anti-allergic efficacy of the traditional Chinese medicine composition was investigated using the hyaluronidase inhibition method. Take 0.1 mL of CaCl2 solution (0.25 mmol / L) and 0.5 mL of hyaluronidase solution (100 U / mL) and react in a water bath at 37℃ for 20 min; add 0.5 mL of each traditional Chinese medicine composition sample and incubate for 20 min; then add 0.5 mL of sodium hyaluronate solution (0.5 g / L), react for 30 min, and then remove and cool for 5 min; add 0.1 mL of sodium hydroxide solution (4 mol / L) and 0.5 mL of acetylacetone solution (3.5 mL of acetylacetone dissolved in 50 mL of 1.0 mol / L sodium carbonate solution), boil in a water bath for 15 min, and then immediately transfer to an ice water bath for 5 min; add 1 mL of Ehrlich reagent (0.8 g of p-dimethylaminobenzaldehyde dissolved in 15 mL of concentrated hydrochloric acid and 15 mL of anhydrous ethanol), and dilute with 3 mL of anhydrous ethanol, place at 25℃ for 20 min for color development, and measure its absorbance at 540 nm, with dipotassium glycyrrhizate as a control. The inhibition rate of hyaluronidase is calculated according to the following formula (2):

[0177] (2)

[0178] In the formula: A—absorbance of the control solution (using acetate buffer solution instead of the sample solution); B—absorbance of the control blank solution (using acetate buffer solution instead of the sample solution and enzyme solution); C—absorbance of the sample solution; D—absorbance of the sample blank solution (using acetate buffer solution instead of the enzyme solution).

[0179] The results obtained by the above testing method are shown in Table 2.

[0180] Table 2: Results of Hyaluronidase Activity Inhibition Test of Traditional Chinese Medicine Composition

[0181]

[0182] As shown in Table 2, the hyaluronidase inhibition performance of the traditional Chinese medicine compositions prepared in Examples 1-11 is higher than that of Comparative Examples 1-5, indicating that the traditional Chinese medicine compositions prepared in this application have excellent anti-allergic and anti-inflammatory effects, among which the anti-allergic and anti-inflammatory effects of Examples 1-6 are even better.

[0183] Experimental Example 4: Test of the Inhibition of Inflammatory Factor NO by Traditional Chinese Medicine Composition

[0184] The inhibitory activity of the inflammatory factor NO in the traditional Chinese medicine composition samples prepared in Examples 1-11 and Comparative Examples 1-5 was tested, and the test method is as follows:

[0185] RAW 264.7 cell suspension concentration was adjusted and added to 96-well cell plates. The cells were cultured overnight at 37°C and 5% CO2 for detection. NMN was diluted to a non-cytotoxic concentration with LPS-containing cell culture medium before being added. Sample groups consisted of traditional Chinese medicine compositions from Examples 1-11 and Comparative Examples 1-5, respectively, added to the above culture medium. LPS-containing culture medium served as the negative control (NC), the positive control group (PC) was added with culture medium containing vitamin A and LPS, and LPS-free cell culture medium served as the blank control (BC). Cells were cultured for 20-24 hours after sample addition. After the treatment, the content of the inflammatory mediator NO in the supernatant was determined using Griess reagent. The calculation method for NO is shown in formula (3):

[0186] (3)

[0187] Where: OD sample —Absorbance of the sample group; OD PC —Absorbance of the positive control group.

[0188] The results obtained by the above testing method are shown in Table 3.

[0189] Table 3: Test results of the inhibition of inflammatory factor NO by traditional Chinese medicine composition

[0190]

[0191] Experimental Example 5: Test of the Inhibition of Inflammatory Factor IL-6 by Traditional Chinese Medicine Composition

[0192] The inhibitory activity of the inflammatory factor IL-6 in the traditional Chinese medicine composition samples prepared in Examples 1-11 and Comparative Examples 1-5 was tested, and the test method is as follows:

[0193] RAW264.7 cell suspension concentration was adjusted and added to 96-well cell plates. The cells were cultured overnight at 37°C and 5% CO2 for detection. The cells were diluted with LPS-containing cell culture medium to a non-cytotoxic concentration before addition. Sample groups consisted of traditional Chinese medicine compositions from Examples 1-11 and Comparative Examples 1-5, respectively, added to the above culture medium. LPS-containing medium served as the negative control (MC), and LPS-free cell culture medium served as the blank control (BC). Positive controls diluted with LPS-containing cell culture medium served as the positive control (PC). Cells were cultured for 20-24 hours after addition. After the reaction, the supernatant was collected, and the IL-6 content was detected according to the IL-6 ELISA kit operating procedure. The calculation method for IL-6 is shown in equation (4):

[0194] (4)

[0195] Where: T—mean value of inflammatory factor IL-6 in the negative control group; NC—mean value of inflammatory factor IL-6 in the experimental group.

[0196] The results obtained by the above testing method are shown in Table 4.

[0197] Table 4: Test results of traditional Chinese medicine composition inhibiting the inflammatory factor IL-6

[0198]

[0199] As shown in Tables 3 and 4, the traditional Chinese medicine composition has a good inhibitory effect on inflammatory factors IL-6 and NO. In addition, the inhibitory effect of Examples 1-11 is more obvious compared with Comparative Examples 1-5, indicating that the traditional Chinese medicine composition after reasonable compounding has excellent anti-inflammatory properties.

[0200] The technical features of the above embodiments can be combined in any way. For the sake of brevity, not all possible combinations of the technical features in the above embodiments are described. However, as long as there is no contradiction in the combination of these technical features, they should be considered to be within the scope of this specification.

[0201] The embodiments described above are merely illustrative of several implementations of the present invention, and while the descriptions are relatively specific and detailed, they should not be construed as limiting the scope of the invention patent. It should be noted that those skilled in the art can make various modifications and improvements without departing from the concept of the present invention, and these all fall within the protection scope of the present invention. Therefore, the protection scope of this invention patent should be determined by the appended claims.

Claims

1. A traditional Chinese medicine composition with soothing and restorative effects, characterized in that, By weight, the traditional Chinese medicine composition is made of 10-20 parts of *Ampelopsis japonica*, 8-20 parts of *Elsholtzia ciliata*, 1-10 parts of *Angelica sinensis*, and 1-10 parts of *Uncaria rhynchophylla*. The *Ampelopsis japonica* is selected from *Ampelopsis japonica* medicinal material and / or *Ampelopsis japonica* extract. The *Elsholtzia ciliata* is selected from *Elsholtzia ciliata* medicinal material and / or *Elsholtzia ciliata* extract. The *Angelica sinensis* is selected from *Angelica sinensis* medicinal material and / or *Angelica sinensis* extract. The *Uncaria rhynchophylla* is selected from *Uncaria rhynchophylla* medicinal material and / or *Uncaria rhynchophylla* extract.

2. The traditional Chinese medicine composition with soothing and restorative effects according to claim 1, characterized in that, The total polyphenol content in the white peony root is ≥8% by mass; The extract of *Bletilla striata* was prepared by extracting the medicinal material with an extraction solvent, wherein the extraction solvent was ethanol with a mass fraction of 70%-80%; the extraction process also included purification treatment, wherein the extract was subjected to column chromatography, wherein the column chromatography included D101 and / or AB-8 macroporous resin; The total flavonoid content in the *Elsholtzia ciliata* is ≥5% by mass; the *Elsholtzia ciliata* extract is prepared by supercritical extraction of the *Elsholtzia ciliata* medicinal material, wherein the solvent for supercritical extraction is 70%-80% ethanol by mass, and the supercritical extraction includes supercritical CO2 extraction, and the extraction pressure is 20MPa-40MPa. Furthermore, the coumarin content in the *Angelica sinensis* is ≥3% by mass; The extract of Angelica sinensis was prepared by extracting Angelica sinensis from the medicinal material of Angelica sinensis var. sinensis using an extraction solvent, wherein the extraction solvent is 70%-80% by mass of ethanol; the extraction process also includes purification treatment, wherein the extract is subjected to column chromatography, wherein the column chromatography includes AB-8 macroporous resin. Furthermore, the catechin content in the catechin vine is ≥15% by mass; the catechin vine extract is prepared by supercritical extraction of the catechin vine medicinal material, wherein the solvent for supercritical extraction is 70%-80% ethanol by mass, the supercritical extraction includes supercritical CO2 extraction, and the extraction pressure is 20MPa-40MPa.

3. The traditional Chinese medicine composition with soothing and restorative effects according to claim 1, characterized in that, The traditional Chinese medicine composition also includes a solvent, which comprises one or more of a polyol and water.

4. The traditional Chinese medicine composition with soothing and restorative effects according to claim 2, characterized in that, The ratio of the total mass of the above-mentioned *Ampelopsis japonica*, *Elsholtzia ciliata*, *Angelica sinensis*, and *Uncaria rhynchophylla* to the mass of the solvent is (0.5-1.5):(50-70); the mass ratio of the above-mentioned *Ampelopsis japonica* and *Angelica sinensis* to the extraction solvent is 1:(10-20). And / or, the temperature of supercritical extraction is 40℃-50℃; the separation pressure of supercritical extraction is 5MPa-10MPa; the separation temperature of supercritical extraction is 30℃-70℃.

5. A method for preparing the traditional Chinese medicine composition with soothing and restorative effects according to any one of claims 1 to 4, characterized in that, Includes the following steps: A traditional Chinese medicine composition with soothing and restorative effects was prepared by mixing Bai Lian, Shi Xiang Ru, Zhong Chi Mao Dang Gui, and Catechu Gou Teng. Microfluidic treatment was used during the mixing process.

6. The method for preparing the traditional Chinese medicine composition with soothing and repairing effects according to claim 5, characterized in that, The operating temperature of the microjet process is 0℃-70℃, and the operating pressure of the microjet process is 1000psi-30000psi; solvents may also be added during the mixing process.

7. A topical preparation, characterized in that, The topical preparation is made with the traditional Chinese medicine composition with soothing and repairing effects as described in any one of claims 1 to 4, or the traditional Chinese medicine composition with soothing and repairing effects prepared by the preparation method described in claim 5 or 6, as the active ingredient and excipients.

8. The topical preparation according to claim 7, characterized in that, The amount of the traditional Chinese medicine composition added to the external preparation is 0.5%-10% by mass; and / or, the excipients include one or more of fillers, diluents, lubricants, wetting agents and binders; and / or, the dosage form of the external preparation includes powders, ointments, pills, tinctures, lozenges, liquids, aerosols or poultices.

9. A cosmetic product, characterized in that, The cosmetic is made with the traditional Chinese medicine composition with soothing and repairing effects as described in any one of claims 1 to 4, or the traditional Chinese medicine composition with soothing and repairing effects prepared by the preparation method described in claim 5 or 6, as the active ingredient and additives.

10. The cosmetic product according to claim 9, characterized in that, The cosmetic product also satisfies at least one of the following features (1) to (4): (1) The amount of the traditional Chinese medicine composition added to the cosmetic is 0.5%-10% by mass; (2) The additives include one or more of the following: humectants, surfactants, antioxidants, and stabilizers; (3) The cosmetic product is available in the form of a paste, liquid, or foam; (4) The product forms of the cosmetics include serums, creams, masks or cleansers.

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